Off-label - CISMeF

Preferred Label : Off-label;

Alternative definition : NCI-GLOSS: Describes the legal use of a prescription drug to treat a disease or condition for which the drug has not been approved by the U.S. Food and Drug Administration.; CDISC-GLOSS: Use of a medical product (such as a drug, biologic, or device) that is unapproved in the region of interest. Note: Not approved for the indication or not approved for the conditions mentioned in the approval (e.g., age group of subjects, dosage, or route of administration). [After FDA Investigational New Drug Safety Reporting Requirements for Human Drug and Biological Products and Safety Reporting Requirements for Bioavailability and Bioequivalence Studies in Humans, Final Rule Sept 2010; After EMA Glossary of Regulatory terms];

Codes from synonyms : CDR0000346523;

Details

Origin ID

C94303;

UMLS CUI

C2986467;

See also inter- (CISMeF)
- Off-Label use [MeSH Descriptor]
Semantic type(s)
- Qualitative Concept [UMLS semantic type]
concept_is_in_subset
- CDISC Glossary Terminology [NCIt concept]
- Clinical Data Interchange Standards Consortium Terminology [NCIt concept]

Keyword's position in hierarchy(ies) :

Main resources

You can consult :

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documents for patients